Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-13 @ 8:11 PM
Study NCT ID:
NCT01823302
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2013-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a New Growing-up Milk on Growth and Nutrient Adequacy in Children With Picky-eating Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-28', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2013-03-28', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors', 'timeFrame': 'baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.', 'description': 'Safety was evaluated through the recording and monitoring of adverse events.'}, {'measure': '•Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors', 'timeFrame': 'baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis', 'description': 'dietary macro- and micro-nutrient intakes'}, {'measure': '•Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors', 'timeFrame': 'baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis', 'description': 'quantitative ultrasound measurements of the radius and tibia'}, {'measure': '•Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors', 'timeFrame': 'baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis', 'description': 'and incidence of common illnesses (diarrhea, and upper and lower respiratory tract infection).'}], 'primaryOutcomes': [{'measure': 'Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors', 'timeFrame': 'baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.', 'description': 'The primary efficacy evaluation was growth, including the change in weight-for-height z-score from baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.'}], 'secondaryOutcomes': [{'measure': 'Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors', 'timeFrame': 'baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis.', 'description': 'Secondary efficacy evaluations included: dietary macro- and micro-nutrient intakes, quantitative ultrasound measurements of the radius and tibia, and incidence of common illnesses (diarrhea, and upper and lower respiratory tract infection).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children with picky-eating behaviors', 'Children aged 2.5 - 5 years', 'reported by caregivers', 'with weight-for-height z-scores ≤ 25th percentile at enrollment'], 'conditions': ['Picky Eating Behaviors']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study was to compare the change in z-scores for growth during a 120-day study period in children with picky eating behaviors who were randomly assigned to receive nutrition counseling only (control group) or nutrition counseling plus an oral milk-based nutritional supplement (study group). The secondary objectives of the study were to compare the following between the control and study groups: a) dietary macro- and micro-nutrient intakes; b) quantitative ultrasound bone measurements of radius and tibia; and c) incidence of common illnesses (diarrhea, upper and lower respiratory tract). The safety objective of the study was to compare the frequency of adverse events (AE) among the control group and study group subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '30 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 30-60 months with PE behavior as reported by caregivers and whose weight-for-height was ≤25th percentile according to World Health Organization (WHO) Child Growth Standards were eligible for inclusion.\n\nExclusion Criteria:\n\n* Current acute or chronic illness, food allergies, lactose intolerance, dietary restrictions precluding dairy foods, any genetic disorder that may compromise growth and/or food intake, cognitive or developmental disorders, or medications that may influence study outcomes.'}, 'identificationModule': {'nctId': 'NCT01823302', 'briefTitle': 'Effect of a New Growing-up Milk on Growth and Nutrient Adequacy in Children With Picky-eating Behaviors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Effect of a New Growing-up Milk on Growth and Nutrient Adequacy in Children With Picky-eating Behaviors', 'orgStudyIdInfo': {'id': '9601A1-4000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'nutritional counseling', 'description': 'nutritional counseling', 'interventionNames': ['Other: nutritional counseling']}, {'type': 'OTHER', 'label': 'nutritional counseling and milk-based supplement', 'description': 'nutritional counseling plus oral milk-based nutrition supplement', 'interventionNames': ['Dietary Supplement: nutrition counseling plus oral milk-based nutritional supplement']}], 'interventions': [{'name': 'nutrition counseling plus oral milk-based nutritional supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Study group subjects were instructed to consume at least 2 servings (230 mL per serving) of an oral milk-based nutritional supplement daily, in addition to their regular diet, for a total of 120 (±3) days.', 'armGroupLabels': ['nutritional counseling and milk-based supplement']}, {'name': 'nutritional counseling', 'type': 'OTHER', 'description': 'nutritional counseling', 'armGroupLabels': ['nutritional counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Xinhua Hospital Affiliated to Shanghai Jiaotong', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiaoyang Sheng, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital Affiliated to Shanghai Jiaotong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}